Gradin 2004.
Methods | Randomised controlled trial I. Masking of randomisation ‐ low risk II. Masking of intervention ‐ low risk III. Masking of outcome assessment ‐ low risk IV. Completeness of follow‐up ‐ high risk | |
Participants | 120 full‐term infants at 3 to 5 days of age undergoing venepuncture for metabolic screening Exclusion criteria: feeding problems or suspicion of illness Group 1: 27 neonates Mean (range) GA ‐ 39.4 (37 to 42) weeks Mean (range) BW ‐ 3638 (2325 to 4425) grams Group 2: 29 neonates Mean (range) GA ‐ 39.5 (37 to 42) weeks Mean (range) BW ‐ 3637 (2700 to 4830) grams Group 3: 26 neonates Mean (range) GA ‐ 39.4 (37 to 42) weeks Mean (range) BW ‐ 3442 (2185 to 4560) grams Group 4: 29 neonates Mean (range) GA ‐ 39.4 (37 to 42) weeks Mean (range) BW ‐ 3660 (3025 to 4950) grams | |
Interventions | Group 1: Breastfeeding and 1 ml sterile water
Group 2: Breastfeeding and 1 ml 30% glucose
Group 3: Fasting and 1 ml sterile water
Group 4: Fasting and 1 ml 30% glucose For breastfed group, breastfeeding was allowed for as long as the infant wanted within 45 minutes prior to blood sampling For the fasting group, blood sampling performed at least 2 hours after the last feed Venepuncture was done 1 minute after giving 30% glucose or sterile water |
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Outcomes | PIPP Visual Analogue Scale Median crying time | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | Low risk | Adequate |
Blinding (performance bias and detection bias) All outcomes | Low risk | Masking was done by blinding the observer as to the assignments to study groups |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Some infants had to be excluded from the analysis because of missing data (problems with video tapes) |
Selective reporting (reporting bias) | Low risk | All patients were accounted for |
Other bias | Unclear risk | Protocol not available to compare |